Discover our tailored solutions to navigate your regulatory journey with confidence and ease.
Navigating international trade regulations demands expertise and strategic insight. Our team transforms complex import requirements into clear, actionable pathways.
We work directly with CDSCO (Central Drugs Standard Control Organisation), DCGI, and respective State FDA authorities to facilitate drug approvals, ensuring that all submissions align with Indian regulatory guidelines.
Yes, we provide complete guidance for securing Form 10, Form 11 (Import License) and Form 25, Form 28 (Manufacturing Licenses) as per the Drugs and Cosmetics Act and Rules in India, including document preparation, filing, and follow-up with officials.
We prepare businesses for regulatory audits conducted by CDSCO or State Drug Inspectors by ensuring proper documentation, compliance readiness, and handling technical responses during inspection or query stages.
Regulatory processes in India involve multiple forms, technical dossiers, and strict compliance checks. Professional support helps you avoid delays, prevent license rejections, and stay compliant with Indian legal frameworks, ensuring smooth market entry and operations.
The Medical Devices industry is complex and ever-evolving. Our regulatory affairs specialists provide tailored solutions to ensure compliance and facilitate market access.
Medical devices in India are regulated by the CDSCO under the Medical Device Rules (MDR) 2017. We coordinate with CDSCO, DCGI, and State Licensing Authorities to streamline registration and regulatory approvals.
Yes, we assist in obtaining Form MD-14/15 for Import Licenses and Form MD-3/5 for Manufacturing Licenses, ensuring full compliance with the Medical Device Rules, 2017, including documentation, application filing, and regulatory follow-up.
We guide you through clinical/performance evaluation protocols, documentation as per ISO and MDR standards, and help ensure your device meets safety and efficacy requirements mandated by CDSCO.
The classification system (Class A, B, C, D) and compliance requirements under Indian MDR 2017 can be complex. Professional guidance ensures accurate documentation, faster approvals, and prevents regulatory non-compliance or delays in market entry.
Navigating the complex landscape of biological products requires specialized knowledge and expertise. Our team is dedicated to ensuring your compliance and success in this highly regulated sector.
Biological products such as vaccines, biosimilars, blood products, and recombinant proteins are regulated by CDSCO under the Drugs and Cosmetics Act. Approvals are overseen by the office of the DCGI, with technical evaluation by expert bodies like RTPAC and SEC committees.
Yes, we assist with filing Form 44 for Biologicals, preparation of CTD/ACTD dossiers, coordination with CDL Kasauli, RCGM, GEAC, and managing the complete approval cycle as per Indian regulatory protocols.
We help prepare CMC documentation, stability data, pre-clinical and clinical trial submissions, and ensure alignment with CDSCO, ICMR, and WHO TRS guidelines, reducing the risk of query letters or application holds.
Biological products undergo stricter scrutiny, multi-agency review, and require extensive technical justification. Expert support ensures regulatory accuracy, faster clearances, and hassle-free interaction with Indian health authorities.
Navigating international trade regulations demands expertise and strategic insight. Our team transforms complex import requirements into clear, actionable pathways.
We provide import registration support across major global markets including the US, EU, UK, Canada, Australia, and emerging markets in Asia, Latin America, and the Middle East. Our expertise spans diverse regulatory systems, from FDA requirements to EMA procedures and country-specific frameworks.
Requirements vary by market but commonly include certificates of analysis, manufacturing licenses, good manufacturing practice (GMP) certificates, product specifications, labeling approvals, and country-of-origin documentation. We create a customized checklist for your specific product and destination markets to ensure nothing is missed.
We develop a centralized compliance strategy that identifies common requirements and country-specific nuances. Our team maintains updated knowledge of regulatory changes across markets, helping you avoid delays and ensure simultaneous or sequential market entries according to your business priorities.
Common issues include incomplete documentation, translation errors, non-compliant labeling, and missed regulatory updates. We prevent these through thorough pre-submission reviews, collaboration with local regulatory experts, and proactive monitoring of regulatory changes that could impact your registrations.
Navigating the complex landscape of nutraceutical regulations can be daunting. Our team provides tailored support to ensure compliance and success.
Nutraceuticals, health supplements, and functional foods are regulated by the FSSAI (Food Safety and Standards Authority of India) under the FSS (Nutraceuticals) Regulations, 2016. For certain borderline products, coordination with CDSCO may also be required.
Yes, we support clients in obtaining FSSAI Central/State License, Product Approval (Form I & II), and Import Clearance via FICS, ensuring proper documentation and regulatory alignment for smooth approvals.
We guide you on labeling compliance, permissible health claims, ingredient approvals, stability data, and safety documentation to ensure products fully comply with FSSAI and Legal Metrology guidelines, avoiding penalties or product recall.
The nutraceutical category often overlaps with pharma and food regulations, which can lead to confusion and delays. Professional guidance helps you choose the correct regulatory pathway, ensure compliant documentation, and accelerate your market launch.
Navigating the regulatory landscape for food products can be complex. Our team provides tailored guidance to ensure compliance and success.
Food products in India are regulated by the FSSAI (Food Safety and Standards Authority of India) under the Food Safety and Standards Act, 2006. We ensure your products meet FSSAI guidelines for safe market entry.
Yes, we assist with FSSAI Central/State License, Product Approval, Formula Validation, and Label Compliance Review, ensuring all legal and technical requirements are met before launching your product.
We provide guidance on HACCP, GMP, Packaging & Labeling Regulations, Shelf-Life Stability Data, and Mandatory Declarations, helping you stay fully compliant during inspections and audits by FSSAI or local authorities.
Food regulations in India are frequently updated, and non-compliance can lead to license suspension, product seizure, or penalties. Expert support ensures smooth approvals, correct documentation, and faster market access without regulatory hurdles.
Navigating the complex landscape of cosmetics regulations can be daunting. Our team simplifies the process, ensuring compliance and success.
Cosmetics in India are regulated by the CDSCO under the Drugs and Cosmetics Act, 1940, along with additional guidelines from the Bureau of Indian Standards (BIS) for ingredient safety, labeling, and compliance.
Yes, we help with obtaining Form 42/43 for Cosmetic Import Registration and Form 31/32 for Manufacturing Licenses, including dossier preparation, ingredient safety review, and coordination with CDSCO authorities.
We review INCI names, ingredient restrictions, claims, packaging declarations, and shelf-life documentation, ensuring alignment with CDSCO and BIS labeling standards, preventing customs delays or market non-compliance.
Incorrect documentation or non-compliant claims can lead to import rejection, product recall, or penalties. Professional regulatory guidance ensures smooth approvals, transparency with authorities, and faster product launches in the Indian market.
The path to drug approval demands more than paperwork. We transform regulatory complexity into a clear roadmap for breakthrough medications.
The timeline varies based on drug classification. New drugs typically take 18-24 months, while already-approved drugs in other markets may qualify for expedited review (6-12 months). Generic drugs often have shorter timelines. Our team helps accelerate the process by ensuring complete, compliant submissions from the start.
Yes, we provide end-to-end support for both import licenses (Form 10) and manufacturing licenses (Form 25/28). Whether you’re bringing in finished products or setting up local production, we guide you through facility inspections, documentation, and regulatory compliance.
We don’t just file paperwork—we develop strategic roadmaps tailored to your drug’s profile. Our expertise helps identify the fastest approval pathway, anticipate regulatory questions, and prepare robust responses that prevent delays and rejections.
Absolutely. We help design clinical trial protocols that meet regulatory standards, coordinate with approved testing facilities, and manage submissions for bioequivalence studies, stability testing, and other performance evaluations required for approval.
Contact AKB Consultancy today to explore tailored solutions for your regulatory needs.